a-tune tick@lab – the IACUC and IBC’s New Electronic Submission and Review System The Institutional Animal Care and Use Committee (IACUC) and Institutional Biosafety Committee (IBC) has transitioned to an electronic system for submission, review, and maintenance of IACUC and IBC applications. The software also integrates research, teaching and testing protocols, animal procurement and management, as well as veterinary medical records. Cara Loy - ORR: 294-4673, [email protected]IACUC and IBC related topics Software functionality Jen Walker, a-tune project manager - AV Office: 294-8964, [email protected]Attending Veterinarian related topics Software functionality Brian Carney - LAR: 294-0536, [email protected]Laboratory Animal Resources Software functionality 1
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a-tune tick@lab – the IACUC and IBC’s New Electronic Submission and Review System
The Institutional Animal Care and Use Committee (IACUC) and Institutional Biosafety Committee (IBC) has transitioned to an electronic system for submission, review, and maintenance of IACUC and IBC applications. The software also integrates research, teaching and testing protocols, animal procurement and management, as well as veterinary medical records.
IACUC and IBC applications are completed, signed, and submitted completely in the system – no more hand-written signatures or Word document-based applications.
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• Amendments are made within the existing approved protocols which means the most current version is always available
• Since this is a web-based system, you can access your protocols from anywhere at anytime with your username and password
• a-tune has a mobile version for tablets and phones
• You will be able to track the progress of your submissions based on the document status of your protocol
• We customized the software extensively to match our current forms and review processes as much as possible
• ORR, AV, and LAR have worked together to make this a one-stop shop from protocol submission to animal ordering and veterinary records
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The system administrators must add users to the a-tune software before personnel, including the PI, are allowed access to the system.
Fill out the New User Request excel file that is available on the ORR website, under IACUC or IBC a-tune Program Information https://www.compliance.iastate.edu/committees/iacuc/a-tune-program-information
The person listed in the PI column will have a team created and all personnel listed on the rows will be on their team.
Each excel file would have the same PI name in all rows and that PI’s name will be the name of a Team.
To have Co-investigator status, mark the columns “Will be on IACUC or IBC protocols” AND “Will edit IACUC or IBC protocols.”
Use an X in the cells under the column headings that apply to each person
You will need to have ISU’s virtual private network (VPN) set up on devices to access the system when not connected to the ISU network. Instructions are found on the ITS website: https://www.it.iastate.edu/services/vpn
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The software only sends one email for status changes.
Please be sure to keep this in mind and respond promptly.
The IACUC and IBC Office won’t be reminding you if you have something pending.
Please note: you will receive emails as the protocol moves through the process. Some emails do not require any action. Be sure to read the email to determine if action it required.
If you let a protocol expire, you will have to submit a new protocol to reestablish approval. However, there is a duplicate file button in the right-click menu of the file-level that will make this quite easy.
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https://protocols.its.iastate.edu/tickatlab
Or click on the Tick@Lab link in OKTA.
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The exercises and practice should be done in this TEST environment.
The PRODUCTION environment must be used for any actual protocols: https://protocols.its.iastate.edu/tickatlab
Place the URL on the slide into your browser’s address bar and hit enter.
The Log In Pop Up window will appear.
Enter your NetID in the User Name Field.
Enter your normal password for your email in the Password field.
By registering for this training session, a profile in the TEST environment was made for you. To gain access to the PRODUCTION environment, fill out the excel file for requesting new users from https://www.compliance.iastate.edu/committees/iacuc/a-tune-program-information and email it to [email protected].
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This is an example of a homepage in tick@lab for a PI.
Other roles may have slightly different modules visible and available for use.
Basic controls:
• Home – takes you back to the homepage
• Switch to mobile – makes the controls work better on mobile devices, replaces right clicks with hover hands to access that menu
• Help – pop-up with a lot of help information for the system. We recommend using this as a helpful resource
• The Launch Pad tab contains protocols, orders and animal management features
• The My tick@lab tab contains any tasks you may be assigned
• Profile – user profile information (name, title, email, etc.)
• Refresh – refreshes the page (use this instead of the browser refresh)
• Logout – logs out of a-tune
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Many controls in a-tune tick@lab rely on right click drop down menus.
On Mac computers, the CNTL key can be held down while clicking to mimic a right click.
On iPads, you can switch to “MOBILE VIEW”, which will create a hover hand at sections where right clicking is required.
Click on the hand to open that menu and click again to select an option.
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The IACUC and IBC protocol forms are located in the “Protocols” section of a-tune tick@lab, now located on the Home Page.
If you have navigated away from the homepage, access them by clicking on “Protocols” in the dark blue left side column of options, or click “Home”.
If you only see one option, either IACUC or IBC, that means you have access only to that committee. You may request access for the other one from the Office for Responsible research (compliance.iastate.edu) if you want to submit the other type of protocol.
The controls are the same for both tabs. The IACUC area holds your IACUC protocols. The IBC area holds your IBC protocols.
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A list of protocol files will open.
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You may have protocols that you have not put in. The a-tune administration team have added test data based on actual protocols in the TEST environment.
You may have protocols in the PRODUCTION environment that you have not added yourself. LAR staff have added skeleton protocols (with much of the protocol information missing) in order to utilize the animal management portion of the software.
You will need to add any of your protocols to the PRODUCTION environment and the animals on the skeleton protocol will be moved over to the protocol you enter.
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The file is the protocol which contains a group of documents. Documents are different versions of the protocol. The user must open the File in order to see the list of documents inside.
Files are opened by clicking on the blue text of the protocol number. (Clicking on the folder icon does NOT open the folder)
Documents must be checked out for the user to be able to edit them. Documents must be checked back in for other users to be able to check them out and then edit them.
Left clicking on the File title opens or closes it. Right clicking on a File title opens a menu of actions.
Left clicking on the Document title opens the document. Right clicking on a Document title opens a menu of actions.
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The File right click menu allows you to duplicate the file or create an IBC from an IACUC. This menu would also allow you to change the title of the file by choosing Details File and editing the Title field.
The Document right click menu allows you to open the document, check it out, print it, move it to the next workflow step such as “For signature”, or start an annual review or amendment of an approved protocol.
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Only one person may have a document checked out at a time, and only that person may edit the protocol at that time.
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Only one person may have a document checked out at a time, and only that person may edit the protocol at that time.
Documents in an editable status may be checked out. This includes documents in Draft, For Signature, Signatures, For Revision, Amendment, and Annual Review.
Approved documents are final and non-editable versions and thus are may not be checked out or edited.
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You can tell who has a document checked out in the Checked-out by column
If you wish to edit a protocol that another user has checked out, please contact them
If a colleague has the document checked-out and they are out of the office (not working on the protocol), ORR also has the capability of checking-in a document for you.
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Pre-set filters are available in the “My Filter Sets” drop-down menu. These are common filters used across all users.
If instead you set the filters manually, you must also Click on the Apply Filter Button.
If you are seeing a list that has been filtered and then want to see all files, click on the Reset Filter button.
You can also make custom filters by choosing parameters in the Document filter, and then clicking on the Apply Filter button. The list of files and documents under the word files will populate with only protocols that meet your criteria.
Click the Reset filter button to clear the filter you’ve used to make the list of files and documents complete.
If the document filter for Version is set to “Last, Active”, you will only see the most recent version of that document listed under a file. If a protocol is approved, you will only see the approved version, unless you have started an amendment or annual review, in which case you will see the last approved version AND the amendment or renewal version that is in progress. If “Last, Active” is NOT engaged, you’ll see every version that protocol has gone through.
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Clicking on the New button launches a new protocol in a pop-up window.
If you click New, and nothing happens, be sure you have allowed pop-up windows and then click New again.
The type of protocol (IACUC or IBC) that is launched correlates with which Protocols area you are in. If you are in the IACUC section of the Protocols area, it will say IACUC at the top left corner of the main window, and the New button will launch an IACUC protocol. If you are in the IBC section of the Protocols area, it will say IBC at the top left corner of the main window and the New button will launch an IBC protocol.
If you can not see the New button, click on the sign just left of the word “Files”. This opens the list of files and documents and that is where the New button is located.
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Chrome: when a pop up is blocked, note the red box with a white x in the address bar
Click on this icon and allow popups for the tick@lab site
Clicking the New button launches this “Initiate File and Document Wizard” window.
The Document template is automatically filled with IACUC if you were in the IACUC section when you clicked the New button, or IBC if you were in the IBC section when you clicked the new button.
Proceed by clicking the Next button.
If you want to create an IBC protocol but you see “IACUC Protocol” in the document template drop down, you must close that window. You go the Protocols area on the main menu and click on IBC. Then click on the New button, and this “Initiate File and Document Wizard” window will now have the IBC template automatically in the Document Template area.
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This is where you add your title. If you need to change the title later, you may do so within the document on the General Information tab and for the File from the File right click menu, Details File option.
Notice that the Protocol Number is auto-generated.
The number format will be either:
IACUC – 2 digit year- a 3 digit unique ID number
IBC – 2 digit year – 3 digit unique ID number
Click the “Save and open document” button. This takes you into the protocol form.
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Notice in the middle section of the page there is a Protocol Category section with IACUC type. If you had created a new IBC, this would say IBC type. The drop down allows you to choose the type of protocol you would like to create. This mimics our previous paper system so you may choose from the following options:
For IACUC:
-Research
-Teaching
-Breeding
For IBC:
-Research/Teaching
-Breeding
-Field Release
-Exempt
When you select a type, the tabs on the left and the questions throughout the form change based on the content needed for that protocol type. For instance, breeding protocols are the only type with breeding related questions.
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The attachments window can be used to add any additional reference material to your protocol (i.e. grants, permits, tables, journal articles, etc.)
To add an attachment follow the following steps:
• Click the “Attachments” button in the menu bar
• In the pop-up, make sure the correct tab on the left is selected where the attachment is referenced in the protocol.
• Click “Choose File”, and find your attachment wherever it is saved on your computer
• Click “Open” in the search window
• Add a description of the attachment in the “Description” box
• Click the “Add” button
• Once the file is attached, it will show up in the bottom sections under “Attachments”
• Repeat if necessary for other attachments
• Click the Apply to document button to finalize the attachment process and close the window.
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• A paper clip icon will show up on any tab that has an attachment successfully added.
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Save: Saves the file – use if you want to save and keep working in the protocol.
Save & Check-in: Saves the file and checks it in so that another person could check it out to edit it.
Save New Version: Saves a separate and new version of the file.
Print PDF: You would again choose your type of form. This prints a pdf of the file and displays it in a pop-up window. You can print to paper from the pdf.
Compare Version: Allows you to select a previous version of the file to compare this open version against.
Validation: Runs the file through a series of checks and will display messages at the top of the screen that tells if validations were successful or not.
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The options that appear under Workflow change based on the status the document is in (Draft, For Signature, IACUC/IBC office review, etc.)
From a “Draft” state, the Workflow menu option of “For Signature” moves the protocol into the “Signatures” state to be signed by the PI. This is the first step in submitting to the IACUC/IBC office.
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Notice tabs down the left side. These tabs help group the questions of the protocol.
When you click on a tab, it will turn a darker blue. The content in the middle section of the form will change to include the questions relevant to that tab.
Many of the questions are radio buttons or text boxes. Some questions use software specific controls that we will explain in this training.
We strongly recommend filling out the protocol form starting with the top tab and working down. Some of the questions build on information from previous questions. For instance, the Experimental Design tab questions may not be answered until you have entered information on the Species tab.
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There are Edit selection buttons under each category of personnel and there are several categories. They each have different roles.
The Signers category personnel will be required to sign the protocol before it is allowed to be submitted to the IACUC or IBC Committees.
This system is eliminating the Department Chair signature that was required on the paper form.
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When you click on a person or team to select them, they appear in a list at the very bottom of this window. Be sure to scroll all the way to the bottom to see this list.
Be sure to add PI and CoPI to “research personnel animal ordering” group
Clicking the “+” sign shows a list of teams or groups. Clicking the word “Teams” shows a list of individuals in alphabetical order.
Clicking the green “+” to the right of a group name adds all members within that group.
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When you click on a person or team to select them, they appear in a list at the very bottom of this window. Be sure to scroll all the way to the bottom to see this list.
Be sure to add PI and CoPI to “research personnel animal ordering” group
Clicking the “+” sign shows a list of teams or groups. Clicking the word “Teams” shows a list of individuals in alphabetical order.
Clicking the green “+” to the right of a group name adds all members within that group.
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If you know that a person is in a-tune, but you can’t find them under a certain personnel category, they likely do not have the role that you are trying to put them under. Contact ORR to give that person that role or put this information into the table at the bottom of the page for new personnel – just indicate which role you want this person to have.
Once a person is added to your team, they will always show up in your team, unless you ask ORR to remove them.
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The IACUC or IBC Office will add the people in this table as users in a-tune.
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• Euthanasia training should also be selected for planned and unplanned euthanasia, as the individual performing this will need to have taken training.
• As a reminder, training must be completed prior to submission to the IACUC/IBC office.
• The clear grey boxes (not the blue) are the ones to select.
• Only the CITI and AALAS options are required.
• You may utilize the Optional trainings for your records.
• You must click the Refresh button to have the table populated. If adding personnel to an approved protocol or after the last "refresh", click Refresh button again.
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Multiple species can be added in this pop-up. All species selected will appear under “Current selection” section of the page.
You must click on the text of the species name (not the blue box to the left).
When the species listed at the bottom of the window is complete, click the Apply current selection button.
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Click the “Add new row” button. Fill in the pain category, species and number of animals
If you need more rows, click the “Add new row” button and create as many rows as you need. If you have one species with different pain categories, you use multiple rows, one for each pain category.
**NOTE: The numbers of each species here MUST match with the numbers of each species on the Animal Numbers Tab or the protocol will not be allowed to be submitted. This is one of the validation steps.
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Repeat for each experimental design.
You may add one experimental design or multiple. The number is up to you and what fits best with your protocol.
Teaching protocols – it is recommended to use one experimental design per teaching lab.
Click on the + sign on the line for species to open a drop down list of species (that is from the species you selected on the species tab).
For each experimental design created, a tab will be made and questions under that tab will appear. Each tab needs to be filled out.
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Notice that there is a tab for each experimental design you created on the experimental design tab.
You must add animal numbers on each tab (except on the total tab).
Click the Add/Edit Calculation button to launch a pop-up window.
If the same animals are used for multiple designs, count the animals on the first design and indicate “0” for subsequent designs. Then, clarify this in the animal numbers justification question.
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It is critical that you get the name of the species you want to do the calculation for into the right-hand box.
You can move a species to the right-hand box by double clicking on the species name, or by highlighting the species and clicking on the double arrow.
Click on the blue text that says new row.
The IACUC office only requires a maximum number of animals used. The animal number module has the function to use calculations, but this is not required.
If multiple experiments use the same animals, these animals should only be counted once. If the animals have been accounted for in the first experimental design, use “0” for subsequent calculations.
If you want to learn more about the calculator function of this module, please refer to the Help menu in a-tunes.
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It is critical that you get the name of the species you want to do the calculation for into the right-hand box.
You can move a species to the right-hand box by double clicking on the species name, or by highlighting the species and clicking on the double arrow.
Click on the blue text that says new row.
The IACUC office only requires a maximum number of animals used. The animal number module has the function to use calculations, but this is not required.
If multiple experiments use the same animals, these animals should only be counted once. If the animals have been accounted for in the first experimental design, use “0” for subsequent calculations.
If you want to learn more about the calculator function of this module, please refer to the Help menu in a-tunes.
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You can move to the experimental design and total tabs by clicking on them.
The Total tab shows all numbers for each experimental design.
You can Edit or Delete calculations on the experimental design tabs but not on the total tab.
The animal numbers on the Total tab must match the animal numbers on the species tab’s USDA pain category table of animal numbers.
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You can save your protocol before the validation is successful.
You can NOT submit your protocol to the Committee for review until the validation is successful.
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Click the Add Procedures & Surgeries button.
A pop-up window will open where you can add procedures and surgeries and indicate which species will experience which procedure or surgery.
Two types of Procedures & Surgeries
“Procedures & Surgeries”
Pre-entered
Select, Apply, Add, Accept Selection
“Manually Described Procedures & Surgeries”
You add the Name and Description
Add, Accept Selection
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In the top section, use the + sign to open a list of pre-entered procedures and surgeries. Locate the procedure of interest, click the check box next to it. You may select several at once. Once you have your list, it is important to select the Apply button, and ALSO click the Add button.
If you don’t see the procedure/surgery you want on your protocol, move down to the section labeled Manually Described Procedures & Surgeries. Ignore the Type drop down, we are not using it. Fill in the Name and Description fields and click on the Add button just above the Name.
Each time you click Add, it will add that procedure or surgery to a list at the bottom of this pop-up window under the heading Selected Procedures & Surgeries.
If there are multiple species on an experimental design, be sure to select the appropriate species to each selected procedure or surgery on the “Assign species” tab.
*** It is important to click the “Accept Selection” button when you are done adding procedures and surgeries. This is what adds them into your protocol.
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Fill out both the “Choose Procedures” and “Assign Species” tabs.
Click “Accept Selection” button when finished.
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Please read the pre-entered procedures or surgeries descriptions that are populated from the database, and edit them to reflect what you will actually do for your protocol.
The two stethoscope icon above the text box toggles on and off a track changes type feature.
Red strikethrough indicates deleted text
Green underline indicates added text
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Save one last time before submitting.
Must be in a state that includes a “For Signature” option under workflow (e.g. Draft, For Revision)
The “For Signature” option is the first step in the process for submitting for IACUC or IBC office review.
Adding a comment to the pop-up window is optional.
Do not select “Pre-Review” unless you have a pre-reviewer assigned on the personnel tab. Pre-review is not a pre-review by the IACUC/IBC office. It is intended for a colleague to review the protocol prior to submission to the IACUC or IBC. USDA pre-review is administered by the IACUC office.
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It may seem redundant to send the protocol to the “For Signature” state and then to the “Signatures’ state, but this flow is in place for situations where a graduate student or scientist has created and drafted the protocol. They would send the protocol to the “For Signature” state, and the PI of the protocol would need to log in and sign the protocol in the “Signatures” state.
If you are both the drafter of the protocol and the PI, you do both steps.
As the PI, within the protocol that is in the “Signatures” status, go to Workflow. Click on “Signatures”. A pop up appears. As the PI, click the “Sign” Button. A password is not required here because the User has already supplied that by logging into OKTA before a-tune.
A timestamp of your signature will appear in the pop-up window.
Close the window by clicking the text “Close Window” in the top left corner. This refreshes the database. Closing the window with the top right “X” does not refresh the database. You would want to click on the word Refresh to do so if you closed it that way.
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The protocol is then routed to the office in IACUC or IBC Office Review status.
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If you realize you need to make a change after it’s been submitted, you will need to contact ORR at 294-6288. You won’t be able to make any changes when the protocol is under review.
Any document in the status “For Revision (xxx)” is ready for you as the PI to respond to review comments.
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Clicking the Review button opens a pop-up window. If you don’t see it, look behind your browser window for another window, or allow pop-ups.
Address the comments within the protocol itself, but also respond to the comment in the review module to state if the item has been updated/corrected/etc.
If appropriate, respond with information or justification for not making recommended changes in the protocol itself.
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Comments are made on the tabs that are specific to where the concern is in the protocol.
Note that the “All” tab at the bottom is selected, which is why all comments appear in the main window.
Address the comment within the protocol itself, then say fixed or done in response to a comment.
If you need to provide justification, please do so in the responses area of the comment.
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You must have the document checked out to make any changes into the protocol itself. If you are in the document (protocol), go to the Action menu drop down and select “Check out” to check it out.
Remember to use the Action Menu to Save it before you submit it back to the office for review.
Response to comment can be as simple as “addressed”. The most important thing is making the changes within the protocol itself.
Note once you have clicked IACUC/IBC Office Review, the document will now be in the IACUC/IBC Office Review state again.
The workflow menu does change based on the state the document is in.
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Please note: you will receive emails as the protocol moves through the process. Some emails do not require any action. Only the above document statuses require your attention.
Both Committees:
Draft Status: A user has created and saved a protocol
For Signature: A user has completed the protocol and the PI needs to sign it
Signatures Status: The PI signs the document
For Revision Status: May occur following IACUC (IBC) office Review, DMR review, or a pre-review
IACUC:
IACUC Office Review Status: The document has been submitted to the IACUC office
IACUC eReview and DMR: the committee is currently reviewing the protocol
Full Committee Review Status: The document will be reviewed at the next full
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committee meeting
IBC:
IBC Office Review Status: The document has been submitted to the IBC office
Subcommittee Review Status: The committee is currently reviewing the protocol (annual reviews and minor amendments)
Full Committee Review Status: The document will be reviewed at the next full committee meeting
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Reminder: only one submission can be submitted and in the review process at a time. Keep this in mind if your annual review date is approaching or you have multiple amendments.
You may NOT have an amendment under review and then submit another amendment or annual review concurrently. You will have to wait until the first amendment is approved before you may start another amendment or an annual review.
Only approved protocols have the option to do an annual review or amendment.
Clicking on the annual review or amendment option creates a new version of the document.
If the controls within the protocol are greyed out, go to the Action Menu and click on Check-Out.
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Make changes as desired throughout the form and also fill in the appropriate amendment and/or annual review tab, which have questions specific to an amendment or annual review, respectively.
You can do an annual review and an amendment at the same time:
Select “Annual Review” on the right click drop down menu from the document list.
Make desired changes in the protocol.
Complete both the amendment and annual review tabs.
Only one submission (version) may be in the review process at one time.
Once changes have been made and the protocol is ready for submission, use the workflow menu to send it to For Signatures, then again to Signatures. From within the Signatures status, once the PI clicks the Sign button, the document will automatically be submitted to the IACUC or IBC office.
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The File level of a protocol has a drop-down menu (from a right click) that includes an option to Duplicate File. The Documents of a file do not have this option. You must right click on the text of the File level of a protocol to have this option.
When you choose the Duplicate File option, a new file is generated and it will have a new protocol number and appear in your list of files. It is automatically checked out to the user that duplicated the file.
This new file will have all the information in it that the file used to create it did. It can be edited after the user checks it out.
This is especially useful for 3-year (IACUC) and 5-year (IBC) renewals, and for protocols that you may be taking over for another PI.
Please do thoroughly review all the information in the new document to ensure it reflects how you want to carry out this current protocol.
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This feature is available from the Files and Documents list.
You must right click on the FILE level of the protocol. This does not work for the document level of the protocol.
This is a one-time transfer, so be sure your IACUC is as complete as possible before you create an IBC from it. Click the Yes button to proceed with the IBC creation from this IACUC file.
Going forward, any amendments made to either the IACUC or IBC protocol must be made to both, if relevant.
You will need to have one IACUC for each IBC and vice versa.
Data from the IACUC from the Personnel, General Information, IACUC Information (or Breeding information for a breeding protocol) and EH&S is transferred to the IBC.
However, additional questions are asked on those tabs in the IBC protocol form, so
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please review those tabs and ensure all questions are completed.
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Please leave the auto populated title. You may add a descriptive title of your choice AFTER that title.
Data from the IACUC is transferred to the Personnel, General Information, IACUC Information (or Breeding information for a breeding protocol) and EH&S tabs in the IBC.
However, additional questions are asked on those tabs in the IBC protocol form, so please review those tabs and ensure all questions are completed.
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The compare feature is available from within a protocol (IACUC or IBC).
Under the Action menu, click Compare Version.
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The “Open all” button expands the pop-up window to list all changes found between the two versions.
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Within the protocol itself (versus the pop-up window), changes are also highlighted with yellow orange boxes with the same green underline for insertions and red strikethrough for deletions.
The compare feature will remain on until you click the “Stop comparison” button.
